MAUDE Adverse Event Report: COOPERSURGICAL, INC. PAPETTE,500 PER BOX,CYTYC

Model Number 908006

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Laceration(s) (1946); Discomfort (2330); Foreign Body In Patient (2687)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4), inc.Is currently investigating the reported condition.

Event Description

E-complaint- (b)(4).Report stated"technical support entered into our complaint database on friday detailing a injury to a patient by a papette manufactured by cooper surgical - broomhead from the thinprep collection device come off inside a patient.Patient was referred to the obgyn group, (b)(6).They were able to retrieve the head, but there was a tear to the septum.Severity of the injury and details on how it occurred - hymenal septum 8 to 9mm that tore and will heal on its on (nurse practitioner)/minimal patient discomfort and will heal on its own.Papette 500 per box cytyc 908006 e-complaint- (b)(4).

Event Description

Report stated: " broomhead from the thinprep collection device come off inside a patient.Patient was referred to the obgyn group, women's care south (tufts medical center) in braintree.They were able to retrieve the head, but there was a tear to the septum".1216677-2020-00243-1 908006 papette 500 per box cytyc e-complaint-2020-10-0000173.

Manufacturer Narrative

Investigation no sample returned review dhr distribution history the complaint product was manufactured at csi in march 2019 under work order 254642.Manufacturing record review dhr19mpg002083 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review incoming inspection record review not applicable to this product.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history shows one other similar reported complaint condition.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause see attachment for root cause.Corrective actions no corrective action is required at this time.Coopersurgical will continue to monitor this complaint condition for trends.Was the complaint confirmed? no.

• Brand Name: PAPETTE,500 PER BOX,CYTYC
• Type of Device: PAPETTE,500 PER BOX,CYTYC
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 10719330
• MDR Text Key: 249382069
• Report Number: 1216677-2020-00243
• Device Sequence Number: 1
• Product Code: HHT
• UDI-Device Identifier: 00888937013290
• UDI-Public: 888937013290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K896065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 908006
• Device Catalogue Number: 908006
• Device Lot Number: 254642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other